Stomach lining patch with central fixation

ABSTRACT

A stomach lining patch includes a collapsible frame, a membrane covering the collapsible frame, collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach, and a set of anchoring arms extending from the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.16/629,131, filed Jul. 7, 2017, which is a U.S. 371 Application ofInternational Application PCT/US2017/041066, filed Jul. 7, 2017, whichare herein incorporated by reference in their entireties.

FIELD

The present disclosure relates to medical devices, and moreparticularly, but without limitation, to bariatric surgical therapies.

BACKGROUND

Millions of adults in the United States and elsewhere are obese. Manyadults with obesity further suffer from Type 2 Diabetes Mellitus (T2DM)and/or with hypertension. Obesity related disorders, including diabetes,cost the United States and worldwide healthcare systems hundreds ofbillions of dollars annually.

Bariatric surgeries, such as vertical sleeve gastrectomy and Roux-en-Ygastric bypass, are effective treatments for both obesity and T2DM.Recent clinical studies demonstrated bariatric surgeries generallyprovide significantly more excess weight loss in obese patients ascompared to lifestyle and medical therapies. Some studies have shownthat more than half of bariatric surgery patients also achieve remissionof diabetes within a year of surgery.

SUMMARY

This disclosure includes a stomach lining patch suitable for endoscopicdelivery and implantation. The stomach lining patch is configured tocover an internal surface of a gastric wall of a patient to limitnutrient contact, which can lead to significant weight loss for apatient.

In one example, this disclosure is directed to a stomach lining patchcomprising a collapsible frame, a membrane covering the collapsibleframe, and a set of anchoring arms extending from the collapsible frame.The collapsible frame and the membrane have a collapsed configurationthat is suitable for endoluminal delivery to a stomach of a patient andan expanded configuration that is suitable for lining an internalsurface of a gastric wall of the stomach. The anchoring arms areconfigured to pass through a puncture in the gastric wall and lay flatagainst an outer surface of the gastric wall when the collapsible frameand the membrane are in the expanded configuration lining the internalsurface of the gastric wall.

In another example, this disclosure is directed to an assemblycomprising an endoscopic delivery catheter, and a stomach lining patchin a collapsed configuration within the endoscopic delivery catheter.The stomach lining patch includes a collapsible frame, a membranecovering the collapsible frame, and a set of anchoring arms extendingfrom the collapsible frame. The collapsible frame and the membrane havea collapsed configuration that is suitable for endoluminal delivery to astomach of a patient and an expanded configuration that is suitable forlining an internal surface of a gastric wall of the stomach. Theanchoring arms are configured to pass through a puncture in the gastricwall and lay flat against an outer surface of the gastric wall when thecollapsible frame and the membrane are in the expanded configurationlining the internal surface of the gastric wall.

In a further example, this disclosure is directed to a method ofimplanting a stomach lining patch within the stomach of a patient. Themethod includes inserting an endoscopic delivery catheter through anesophagus of the patient to locate a distal end of the endoscopicdelivery catheter within a stomach of the patient, forming a puncture ina gastric wall of the stomach, and delivering the stomach lining patchin a collapsed configuration to the stomach via the endoscopic deliverycatheter. The stomach lining patch includes a collapsible frame, amembrane covering the collapsible frame, collapsible frame, and a set ofanchoring arms extending from the collapsible frame. The collapsibleframe and the membrane have a collapsed configuration that is suitablefor endoluminal delivery to a stomach of a patient and an expandedconfiguration that is suitable for lining an internal surface of agastric wall of the stomach. The method further includes inserting theset of anchoring arms through the puncture the gastric wall anddeploying the stomach lining patch from the distal end of the endoscopicdelivery catheter to expand the stomach lining patch from the collapsedconfiguration to an expanded configuration. Once deployed, the set ofanchoring arms lay flat against an outer surface of the gastric wall andthe collapsible frame and the membrane line an internal surface of thegastric wall.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description serve to explain the principles of the disclosure.

FIGS. 1A-1B illustrate a stomach lining patch with a central fixation,the stomach lining patch being suitable for endoscopic delivery andimplantation within a patient.

FIGS. 2A-2D are conceptual illustrations of an endoscopic implantationof the stomach lining patch of FIGS. 1A-1B.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

FIGS. 1A-1B illustrate a stomach lining patch 10, which is suitable forendoscopic delivery and implantation within a patient. Morespecifically, FIG. 1A illustrates a top view of the stomach lining patch10, whereas FIG. 1B illustrates a side view of the stomach lining patch10. The stomach lining patch 10 includes a collapsible frame 20, amembrane 30 covering the collapsible frame 20, and a set of anchoringarms 40 that provide central fixation for the stomach lining patch 10.

The collapsible frame 20 is formed from one or more elongated elementsshaped to form a set of concentric interwoven or interconnectedundulating rings, including a first undulating ring 21, a secondundulating ring 22, and a third undulating ring 23, radiating from acenter 25 of the collapsible frame 20. In different examples, theundulating rings may represent separate rings or include a single wirein arranged in a coil to form more than one, such as all, of rings 21,22, 23. The first undulating ring 21 forms a series of petalssurrounding the center 25. The second undulating ring 22 forms peaks andvalleys with the valleys woven through or interconnected with the petalsof the first undulating ring 21. The third undulating ring 23 formspeaks and valleys with the valleys woven through or interconnected withthe peaks of the second undulating ring 22. For example, overlappedapices can be held in place with adhesive or the graft material.

The concentric arrangement of the undulating rings 21, 22, 23 provides acollapsed configuration suitable for endoscopic delivery to a stomach ofa patient, as shown in FIG. 2A, as well as an expanded configurationsuitable for lining an internal surface of a gastric wall of a stomach,as shown in FIG. 2C. The collapsible frame 20, when in the expandedconfiguration, is compliant to remain in contact with the internalsurface of the gastric wall during peristalsis, for example, or othermovement of the stomach wall.

In some examples, the collapsible frame 20 may be formed from a metalmaterial, such as a metal wire. In some examples, the collapsible frame20 may be formed from a superelastic material, such as a nitinol wire.Such examples may allow a collapsed configuration suitable forendoscopic delivery through elastic deformation of the expandedconfiguration. Alternatively, the collapsible frame 20 may be formedfrom a cut tube, such as a nitinol tube. Such examples may provideinterconnected connections between the undulating rings 21, 22, 23.

The collapsible frame 20 serves as a skeleton to support the membrane30, and the membrane 30 covers the collapsible frame 20. The membrane 30is suitable to limit nutrient contact when the stomach lining patch 10is lined against an internal surface of a gastric wall of a stomach. Insome examples, the membrane 30 may include or be formed entirely, orprimarily (e.g., 80% or greater) from expanded polytetrafluoroethylene(ePTFE). Using ePTFE may provide a thin, durable, impermeable materialto limit nutrient contact from lined surfaces of the gastric wall. Insome examples, the membrane 30 may include elastomer imbibing or foldedstructure to allow the membrane 30 to be compliant to remain in contactwith the internal surface of the gastric wall during peristalsis andother movement of a patient.

In some embodiments, the membrane 30 comprises a fluoropolymer, such asan expanded polytetrafluoroethylene (ePTFE) polymer, or polyvinylidenefluoride (PVDF). In some embodiments, the membrane 30 comprises apolyester, a silicone, a urethane, another biocompatible polymer,polyethylene terephthalate (e.g., Dacron®), copolymers, or combinationsthereof.

In some embodiments, the membrane 30 (or portions thereof) is modifiedby one or more chemical or physical processes that enhance one or moreproperties of the material. For example, in some embodiments, ahydrophilic coating is applied to the membrane 30 to improve thewettability and echo translucency of the material. In some embodiments,the membrane 30, or portions thereof, is modified with chemical moietiesthat facilitate one or more of cell attachment, cell migration, cellproliferation, and resistance to or promotion of thrombosis. In someembodiments, the membrane 30, or portions thereof, is modified to resistbiofouling. In some embodiments, the membrane 30, or portions thereof,is modified with one or more covalently attached drug substances (e.g.,heparin, antibiotics, and the like) or impregnated with the one or moredrug substances. The drug substances can be released in situ to promotehealing, reduce tissue inflammation, reduce or inhibit infections, andto promote various other therapeutic treatments and outcomes. In someembodiments, the drug substance is a corticosteroid, a human growthfactor, an anti-mitotic agent, an antithrombotic agent, a stem cellmaterial, or dexamethasone sodium phosphate, to name some embodiments.In some embodiments, a pharmacological agent is delivered separatelyfrom the membrane 30 to the target site to promote tissue healing ortissue growth.

Coatings and treatments may be applied to the membrane 30 before orafter the membrane 30 is joined or disposed on the framework of thestomach lining patch 10. Additionally, one or both sides of the membrane30, or portions thereof, may be coated. In some embodiments, certaincoatings and/or treatments are applied to the membrane 30(s) located onsome portions of the stomach lining patch 10, and other coatings and/ortreatments are applied to the material(s) located on other portions ofthe stomach lining patch 10. In some embodiments, a combination ofmultiple coatings and/or treatments is applied to the membrane 30, orportions thereof. In some embodiments, certain portions of the membrane30 are left uncoated and/or untreated. In some embodiments, the stomachlining patch 10 is fully or partially coated to facilitate or frustratea biological reaction, such as, but not limited to, cell attachment,cell migration, cell proliferation, and resistance to or promotion ofthrombosis.

In some embodiments, a first portion of the membrane 30 is formed of afirst material and a second portion of the membrane 30 is formed of asecond material that is different than the first material. In someembodiments, the membrane 30 includes multiple layers of materials,which may be the same or different materials. In some embodiments,portions of the membrane 30 have one or more radiopaque markers attachedthereto to enhance in vivo radiographic visualization of the stomachlining patch 10, or one or more echogenic areas to enhance ultrasonicvisibility.

In some embodiments, one or more portions of the membrane 30 areattached to the framework of the stomach lining patch 10, such as thecollapsible frame 20 and/or a support structure of the anchoring arms40. The attachment can be accomplished by a variety of techniques suchas, but not limited to, stitching the membrane 30 to the framework ofthe stomach lining patch 10, adhering the membrane 30 to the frameworkof the stomach lining patch 10, laminating multiple layers of themembrane 30 to encompass portions of the elongate members of the stomachlining patch 10, using clips or barbs, or laminating multiple layers ofthe membrane 30 together through openings in the framework of thestomach lining patch 10. In some embodiments, the membrane 30 isattached to the framework of the stomach lining patch 10 at a series ofdiscrete locations thereby facilitating the flexibility of theframework. In some embodiments, the membrane 30 is loosely attached tothe framework of the stomach lining patch 10. It is to be appreciatedthat the membrane 30 may be attached to the framework of the stomachlining patch 10 using other techniques or combinations of techniquesdescribed herein.

In some embodiments, the framework of the stomach lining patch 10 (orportions thereof) is coated with a bonding agent (e.g., fluorinatedethylene propylene or other suitable adhesive) to facilitate attachmentof the membrane 30 to the framework. Such adhesives may be applied tothe framework using contact coating, powder coating, dip coating, spraycoating, or any other appropriate means.

The membrane 30 can adapt to changes in the length and/or diameter ofthe collapsible frame 20 in a variety of manners. In a first example,the membrane 30 can be elastic such that the membrane 30 can stretch toaccommodate changes in the length and/or diameter of the stomach liningpatch 10. In a second example, the membrane 30 can include slackenedmaterial in the low-profile delivery configuration that becomes lessslackened or totally unslackened when the stomach lining patch 10 is inthe expanded configuration. In a third example, the membrane 30 caninclude folded portions (e.g., pleats) that are folded in thelow-profile configuration and less folded or totally unfolded when thestomach lining patch 10 is in the expanded configuration. In otherembodiments, an axial adjustment member is free of the membrane 30. Insome embodiments, combinations of such techniques, and/or othertechniques can be used whereby the membrane 30 can adapt to changes inthe length and/or diameter of the collapsible frame 20.

The anchoring arms 40 extend from the collapsible frame 20 adjacent itscenter 25. The anchoring arms 40 configured to pass through a puncturein a gastric wall and lay flat against an outer surface of the gastricwall when the collapsible frame 20 and the membrane 30 are in anexpanded configuration lining the internal surface of the gastric wall,as shown in FIG. 2C. The anchoring arms 40 may be larger than the holesin the stomach to provide a slight outward radial force on the holes toaid in sealing, e.g., via an interference fit due to the elasticity ofthe tissues.

The anchoring arms 40 lay flat against the external surface of thegastric wall while the collapsible frame 20 lays flat against theinternal surface of the gastric wall to provide apposition forces to thegastric wall surfaces. The collapsible frame 20 and/or the anchoringarms 40 may have preset curves configured to generally conform to thegastric wall surfaces. In some examples, the anchoring arms are radiallyoffset relative to the elements of the collapsible frame 20. Theanchoring arms 40 may represent a series of petal shaped wire framessurrounding the center 25, although any variety of other configurationsof the anchoring arms 40 may serve as suitable alternatives, such assolid petals rather than wire frame petals.

In some examples, the anchoring arms 40 may be formed from a metalmaterial, such as a metal wire. In the same or different examples, theanchoring arms 40 may be formed from a superelastic material, such as anitinol material. Such examples may allow a collapsed configurationsuitable for endoscopic delivery through elastic deformation of theexpanded configuration. The anchoring arms 40 may be formed from asubstantially similar material to that of the collapsible frame 20, suchas part of a cut tube forming the collapsible frame 20. For example, thecollapsible frame 20 and the anchoring arms 40 may include a monolithicframe element forming at least a portion of the collapsible frame 20 andthe anchoring arms 40. In some examples, the collapsible frame 20 andthe anchoring arms 40 may be formed from a single woven wire, such as anitinol wire. Alternatively, the collapsible frame 20 and the anchoringarms 40 may be formed from a cut tube structure, such as a cut nitinoltube. In further examples, the collapsible frame 20 and the anchoringarms 40 may be formed from more than one element including anycombination of wire elements, and/or cut tube elements.

In various examples, the membrane 30 may cover the anchoring arms 40, ormay not cover the anchoring arms 40. In some particular examples, theanchoring arms 40 may be covered in a material that resists ingrowth andadhesion. This may allow the stomach lining patch 10 to be removed laterwithout significant trauma to the surrounding tissues of the gastricwall 102.

Suitable materials for the elongate frame elements of the devicesprovided herein, such as the collapsible frame 20 and the supportstructure of the anchoring arms 40, include a variety of metallicmaterials including alloys exhibiting, shape memory, elastic andsuper-elastic characteristics. Shape memory refers to the ability of amaterial to revert to an originally memorized shape after plasticdeformation by heating above a critical temperature. Elasticity is theability of a material to deform under load and return or substantiallyreturn to its original shape when the load is released. Most metals willdeform elastically up to a small amount of strain. Super-elasticityrefers to the ability of a material to deform under strain to muchlarger degree than typical elastic alloys, without having thisdeformation become permanent. For example, the super-elastic materialsincluded in the frames of some anastomosis device embodiments providedherein are able to withstand a significant amount of bending and flexingand then return or substantially return to the frame's original formwithout deformation. In some embodiments, suitable elastic materialsinclude various stainless steels which have been physically, chemically,and otherwise treated to produce a high springiness, metal alloys suchas cobalt chrome alloys (e.g., ELGILOY™, MP35N, L605), platinum/tungstenalloys. Embodiments of shape memory and super-elastic alloys include theNiTi alloys, ternary shape memory alloys such as NiTiPt, NiTiCo, NiTiCr,or other shape memory alloys such as copper-based shape memory alloys.Additional materials could combine both shape memory and elastic alloyssuch as a drawn filled tube where the outer layer is constructed ofnitinol and the internal core is a radiopaque material such as platinumor tantalum. In such a construct, the outer layer provides thesuper-elastic properties and the internal core remains elastic due tolower bending stresses.

In some embodiments, the elongate frame elements used to construct thedevices provided herein can be treated in various ways to increase theradiopacity of the devices for enhanced radiographic visualization. Insome embodiments, the devices are at least partially a drawn-filled typeof NiTi containing a different material at the core, such as a materialwith enhanced radiopacity. In some embodiments, the devices include aradiopaque cladding or plating. In some embodiments, one or moreradiopaque markers are attached to the devices. In some embodiments, theelongate frame elements and/or other portions of the devices providedherein are also visible via ultrasound.

FIGS. 2A-2D illustrate endoscopic implantation of the stomach liningpatch 10 within a stomach 100 of a patient. The stomach lining patch 10is introduced to the stomach 100 as part of an assembly 60 in acollapsed configuration within the endoscopic delivery catheter 50. Theillustrated portion of the patient's anatomy in FIGS. 2A-2D includes thestomach 100, the esophagus 110, the pylorus 112, and the duodenum 114 ofthe patient's small intestine. The stomach 100 includes the gastric wall102, the antrum 104 and the fundus 106.

As shown in FIG. 2A, the stomach lining patch 10 is delivered to thestomach 100 via the endoscopic delivery catheter 50. In some examples,the stomach lining patch 10 is carried into the stomach 100 proximatethe distal end 52 of the endoscopic delivery catheter 50. In otherexamples, the endoscopic delivery catheter 50 may be passed through theesophagus 110 to locate the distal end 52 within the stomach 100 beforethe stomach lining patch 10 is pushed through a central lumen of theendoscopic delivery catheter 50, for example, by first loading thestomach lining patch 10 in a proximal end (not shown) of the endoscopicdelivery catheter 50 before traversing the length of the central lumenof the endoscopic delivery catheter 50. In such examples, the endoscopicdelivery catheter 50 maybe used to facilitate the endoscopic delivery ofmultiple tools and implants to the stomach 100, such as cameras,surgical tools, and multiple stomach lining patches 10.

In one example technique of implanting the stomach lining patch 10within the stomach 100, a clinician first inserts the endoscopicdelivery catheter 50 through the esophagus 110 to locate the distal end52 of the endoscopic delivery catheter 50 within the stomach 100. Theendoscopic delivery catheter 50 provides access to the stomach 100 forimaging equipment and surgical tools. The clinician then inserts acutting instrument (not shown) through the endoscopic delivery catheter50 to a location on an internal surface of the gastric wall 102. Theclinician forms the puncture 103 in the gastric wall 102.

The clinician may then withdraw the cutting instrument, and deliver thestomach lining patch 10 in a collapsed configuration to the stomach 100via the endoscopic delivery catheter, by pushing the stomach liningpatch 10 through the central lumen of endoscopic delivery catheter withthe plunger 53, as shown in FIG. 2A.

As shown in FIG. 2B, the clinician may then locate the distal end 52 ofthe endoscopic delivery catheter 50 proximate the puncture 103 anddirect the ends of the anchoring arms 40, which protrude from the distalend 52 of the endoscopic delivery catheter 50, through the puncture 103.Once the ends of the anchoring arms 40 are extended through the puncture103, the clinician may partially deploy the stomach lining patch 10 fromthe distal end 52 of the endoscopic delivery catheter 50. Once deployed,the anchoring arms 40 may reside in the peritoneal space and lay flatagainst an outer surface of the gastric wall 102 to minimize the profileof the stomach lining patch 10. The portion of the center of theanchoring arms 40 that passes through the gastric wall 102 should berelatively small to limit trauma to the tissue upon deployment and allowthe puncture 103 to heal rapidly upon removal of the stomach liningpatch 10.

Next, as shown in FIG. 2C, the clinician may deploy the stomach liningpatch 10 from the distal end 52 of the endoscopic delivery catheter 50,e.g., by pushing the stomach lining patch 10 through the central lumenof endoscopic delivery catheter with the plunger 53. Once deployed, thestomach lining patch 10 expands from collapsed configuration within thecentral lumen of the endoscopic delivery catheter 50 to an expandedconfiguration. In the expanded configuration, the membrane 30 and thecollapsible frame 20 line an internal surface of the gastric wall 102.In this expanded configuration, the collapsible frame 20 lays flatagainst the internal surface of the gastric wall 102 such that themembrane 30 and the collapsible frame 20 limit nutrient contact fromlined portions of the internal surface of the gastric wall 102.

As shown in FIG. 2D, the implantation steps described with respect toFIGS. 2A-2C may be repeated for a number of stomach lining patches 10 toline more of the internal surface of the gastric wall 102 and furtherlimit nutrient contact. In some examples, the stomach lining patches 10may overlap one another to fully line large areas of the internalsurfaces of the gastric wall 102. Such stomach lining patches mayeffectively exclude the majority of the hormone producing stomach cells,mimicking a vertical sleeve gastrectomy. As shown in FIG. 2D, forexample, the stomach lining patches 10 may be located to cover differentportions of the gastric wall 102, including portions corresponding tothe stomach body, as well as the antrum 104 and the fundus 106. Indifference examples, the stomach lining patches 10 may be adapted toconform to various stomach geometries. In other examples, the stomachlining patches 10 may be sufficiently compliant to facilitate liningvarious stomach geometries without adaptation.

Various modifications may be made to the techniques disclosed hereinwithin the spirit of this disclosure. For example, whereas the stomachlining patch 10 is described as including a set of the anchoring arms 40that extend through the gastric wall 102 to provide fixation withinstomach, other fixation techniques may be applied instead of or incombination with the full gastric wall thickness fixation provided bythe anchoring arms 40. For example, in other examples, partial gastricwall thickness fixation techniques may be used, such as any combinationof tacks, hooks and/or sutures, such as sutures provided by commercialendoscopic suturing devices. Such examples may utilize modified stomachlining patches 10 with or without the anchoring arms 40.

In various examples, this disclosure covers each of following clauses,as well as the claims provided below, although this disclosure is notlimited by the listings of clauses and claims.

Clause 1: A stomach lining patch comprising: a collapsible frame; amembrane covering the collapsible frame, collapsible frame and themembrane providing a collapsed configuration suitable for endoluminaldelivery to a stomach of a patient and an expanded configurationsuitable for lining an internal surface of a gastric wall of thestomach; and a set of anchoring arms extending from the collapsibleframe and being configured to pass through a puncture in the gastricwall and lay flat against an outer surface of the gastric wall when thecollapsible frame and the membrane are in an expanded configurationlining the internal surface of the gastric wall.

Clause 2: The stomach lining patch of clause 1, wherein the membranecovers the set of anchoring arms.

Clause 3: The stomach lining patch of clause 1, wherein the collapsibleframe and the set of anchoring arms include a monolithic frame elementforming at least a portion of the collapsible frame and the set ofanchoring arms.

Clause 4: The stomach lining patch of clause 1, wherein the collapsibleframe and the set of anchoring arms is formed from a cut tube structure.

Clause 5: The stomach lining patch of clause 1, wherein the collapsibleframe, when in the expanded configuration is compliant to remain incontact with the internal surface of the gastric wall duringperistalsis.

Clause 6: The stomach lining patch of clause 1, wherein the collapsibleframe, when in the expanded configuration, is configured to lay flatagainst the internal surface of the gastric wall and limit nutrientcontact from lined portions of the internal surface of the gastric wall.

Clause 7: The stomach lining patch of clause 1, wherein the membraneincludes expanded polytetrafluoroethylene (ePTFE).

Clause 8: The stomach lining patch of clause 1, wherein the collapsibleframe is formed from Nitinol.

Clause 9: The stomach lining patch of clause 1, wherein the set ofanchoring arms are covered in a material that resists ingrowth andadhesion.

Clause 10: An assembly comprising: an endoscopic delivery catheter; anda stomach lining patch in a collapsed configuration within theendoscopic delivery catheter, the stomach lining patch comprising: acollapsible frame; a membrane covering the collapsible frame,collapsible frame and the membrane providing the collapsed configurationsuitable for endoluminal delivery to a stomach of a patient and anexpanded configuration suitable for lining an internal surface of agastric wall of the stomach; and a set of anchoring arms extending fromthe collapsible frame and being configured to pass through a puncture inthe gastric wall and lay flat against an outer surface of the gastricwall when the collapsible frame and the membrane are in an expandedconfiguration lining the internal surface of the gastric wall.

Clause 11: The assembly of clause 10, wherein the membrane covers theset of anchoring arms.

Clause 12: The assembly of clause 10, wherein the collapsible frame andthe set of anchoring arms include a monolithic frame element forming atleast a portion of the collapsible frame and the set of anchoring arms.

Clause 13: The assembly of clause 10, wherein the collapsible frame andthe set of anchoring arms is formed from a cut tube structure.

Clause 14: The assembly of clause 10, wherein the collapsible frame,when in the expanded configuration is compliant to remain in contactwith the internal surface of the gastric wall during peristalsis.

Clause 15: The assembly of clause 10, wherein the collapsible frame,when in the expanded configuration, is configured to lay flat againstthe internal surface of the gastric wall and limit nutrient contact fromlined portions of the internal surface of the gastric wall.

Clause 16: The assembly of clause 10, wherein the membrane includesexpanded polytetrafluoroethylene (ePTFE).

Clause 17: The assembly of clause 10, wherein the collapsible frame isformed from Nitinol.

Clause 18: The assembly of clause 10, wherein the set of anchoring armsare covered in a material that resists ingrowth and adhesion.

Clause 19: A method of implanting a stomach lining patch within astomach of a patient, the method comprising: inserting an endoscopicdelivery catheter through an esophagus of the patient to locate a distalend of the endoscopic delivery catheter within the stomach of thepatient; forming a puncture in a gastric wall of the stomach; deliveringthe stomach lining patch in a collapsed configuration to the stomach viathe endoscopic delivery catheter, wherein the stomach lining patchincludes: a collapsible frame; a membrane covering the collapsibleframe, collapsible frame and the membrane providing the collapsedconfiguration suitable for endoluminal delivery to the stomach of thepatient and an expanded configuration suitable for lining an internalsurface of a gastric wall of the stomach; and a set of anchoring armsextending from the collapsible frame; inserting the set of anchoringarms through the puncture the gastric wall; deploying the stomach liningpatch from the distal end of the endoscopic delivery catheter to expandthe stomach lining patch from the collapsed configuration to an expandedconfiguration, wherein, once deployed, the set of anchoring arms layflat against an outer surface of the gastric wall and the collapsibleframe and the membrane line an internal surface of the gastric wall.

Clause 20: The method of clause 19, wherein the stomach lining patch isa first stomach lining patch, the method further comprising deploying asecond stomach lining patch from the distal end of the endoscopicdelivery catheter to line more of the internal surface of the gastricwall.

The invention of this application has been described above bothgenerically and with regard to specific embodiments. It will be apparentto those skilled in the art that various modifications and variationscan be made in the embodiments without departing from the scope of thedisclosure. Thus, it is intended that the embodiments cover themodifications and variations of this invention provided they come withinthe scope of the appended claims and their equivalents.

What is claimed is:
 1. A stomach lining patch comprising: a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings; a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach; and a set of anchoring arms extending from the one or more elongated elements of the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the one or more elongated elements of the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall.
 2. The stomach lining patch of claim 1, wherein the membrane covers the set of anchoring arms.
 3. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms include a monolithic frame element forming at least a portion of the one or more elongated elements of the collapsible frame and the set of anchoring arms.
 4. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a cut tube structure.
 5. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame, when in the expanded configuration, are compliant to remain in contact with the internal surface of the gastric wall during peristalsis.
 6. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame, when in the expanded configuration, are configured to lay flat against the internal surface of the gastric wall and limit nutrient contact from lined portions of the internal surface of the gastric wall.
 7. The stomach lining patch of claim 1, wherein the membrane includes expanded polytetrafluoroethylene (ePTFE).
 8. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame are formed from Nitinol.
 9. The stomach lining patch of claim 1, wherein the set of anchoring arms are covered in a material that resists ingrowth and adhesion.
 10. The stomach lining patch of claim 1, wherein the set of anchoring arms are radially offset relative to the one or more elongated elements of the collapsible frame.
 11. The stomach lining patch of claim 1, wherein the set of anchoring arms comprise a plurality of petal-shaped wire frames.
 12. The stomach lining patch of claim 1, wherein the set of anchoring arms comprise a plurality of solid petals.
 13. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a single woven wire.
 14. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a combination of one or more wire elements and one or more cut tube elements.
 15. The stomach lining patch of claim 1, wherein the one or more elongated elements of the collapsible frame comprise an outer layer formed of Nitinol and an internal core formed of a radiopaque material.
 16. The stomach lining patch of claim 1, wherein the interwoven or interconnected undulating rings are concentric.
 17. An assembly comprising: an endoscopic delivery catheter; and a stomach lining patch including: a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings; a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach; and a set of anchoring arms extending from the one or more elongated elements of the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the one or more elongated elements of the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall, wherein the stomach lining patch is in a collapsed configuration within the endoscopic delivery catheter.
 18. The assembly of claim 17, further comprising a plunger configured to push the stomach lining patch out a distal end of the endoscopic delivery catheter to facilitate deployment of the stomach lining patch within a patient.
 19. A method of implanting a stomach lining patch within the stomach of a patient, the method comprising: inserting an endoscopic delivery catheter through an esophagus of the patient to locate a distal end of the endoscopic delivery catheter within a stomach of the patient; forming a puncture in a gastric wall of the stomach; delivering a stomach lining patch in a collapsed configuration to the stomach via the endoscopic delivery catheter, the stomach lining patch including a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings, a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach, and a set of anchoring arms extending from the one or more elongated elements of the collapsible frame; inserting the set of anchoring arms through the puncture the gastric wall; deploying the stomach lining patch from the distal end of the endoscopic delivery catheter to expand the stomach lining patch from the collapsed configuration to an expanded configuration, wherein, once deployed, the set of anchoring arms lay flat against an outer surface of the gastric wall, and the one or more elongated elements of the collapsible frame and the membrane line an internal surface of the gastric wall.
 20. The method of claim 19, wherein the stomach lining patch is a first stomach lining patch, the method further comprising deploying a second stomach lining patch from the distal end of the endoscopic delivery catheter to line more of the internal surface of the gastric wall. 